Kornimate/medical-research-clean huggingface dataset:
iressa in the treatment of brain metastases from non small cell lung cancer

Conditions: Brain Neoplasms; Non Small Cell Lung Cancer

Summary: the aim of the study is to determine if iressa is effective in the treatment of brain metastases from ncslc


Eligibility criteria:
inclusion criteria: * radiologically confirmed brain metastases from non small cell lung cancer * no symptoms due to brain metastases * no previous radiotherapy treatment for the brain metastases exclusion criteria: * no prior chemotherapy * no other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ * any evidence of severe or uncontrolled systemic disease (e.g., unstable or uncompensated respiratory, cardiac, hepatic, or renal disease)

Keywords: non symptomatic brain metastases iressa
evaluation of effectiveness of nutritional counseling in patients after stroke

Conditions: Stroke; Cardiovascular Diseases

Summary: stroke is the leading cause of disability worldwide and the leading cause of death in brazil. it is estimated that about 18 million people will have a stroke in 2015 and approximately one third of these resulting in death. the factors most important modifiable risk for stroke include high blood pressure (hypertension), diabetes, smoking, dyslipidemia, sedentary lifestyle and obesity. acting on these risk factors can be reduced by 88% the risk of another stroke. healthy eating is among the changes in lifestyle that are recommended for prevention and treatment of one of the main risk factors for stroke. studies show that the adoption of the dash diet can significantly reduce blood pressure and the result is even more significant in hypertensive patients, making this diet a new alternative in the prevention and treatment of hypertension and consequently stroke. compliance therapy is a determining factor for success in the treatment of chronic diseases. adherence to long-term treatment in developed countries is around 50% and in developing countries the rates are even lower. the aim of this study is to evaluate the effectiveness of nutritional counseling in an adapted dash style diet on body weight, glycemic control, blood pressure values and improved lipid profile compared to the usual diet without nutritional counseling in patients with stroke within the last 3 months. the hypothesis is that nutritional counseling with an adapted dash style diet reduces cardiovascular risk factors compared with the usual diet without nutritional counseling in patients with stroke within 3 months. the stroke patients will be selected in the hospitalization or in the outpatient clinic of hospital de clínicas de porto alegre in a period up to 3 months after ischemic stroke. the patients will be randomized to one of the 2 groups. in the first visit they will be submitted to a social class and international physical activity questionnaire and they will be submitted to a food frequency questionnaire, measures of weight, height, waist circumference, hip and neck, blood pressure and cholesterol and glucose measurements at the baseline, 30 days and 3, 6, 9 and 12 months. the main endpoints will be the change in the body weight, blood glucose, blood pressure values and lipid profile.

the study will be followed by a evaluation of other endpoints: new stroke, myocardial infarction or cardiovascular death.

Eligibility criteria:
inclusion criteria: * ischemic stroke up to 3 months * modified rankin score \< 4 exclusion criteria: * aphasia * enteral diet * unavailability to follow up the study

Keywords: diet dash stroke nutritional counseling
a clinical study to characterize the pharmacokinetics and the effects of food on oxycodone in healthy volunteers

Conditions: Analgesia; Acute Pain; Chronic Pain; Narcotic Abuse; Opioid-related Disorders

Summary: this is an open-label (both the physician and healthy volunteer know which medication will be administered), single-dose, 5-dosing period study to characterize the pharmacokinetics (process by which oxycodone is absorbed, distributed, metabolized, and eliminated by the body) and the effects of food on the pharmacokinetics of oxycodone. the study will take place over approximately two and a half months and will consist of three phases: a screening visit to determine eligibility for the study, a 5-dosing period treatment phase, and an end-of-study visit.


Eligibility criteria:
inclusion criteria: * healthy male or female subjects between 18 and 55 years of age (inclusive) exclusion criteria: * evidence or history of clinically significant disease; * history of obstructive sleep apnea; * positive urine drug test.

Keywords: bioavailability food effect oxycodone management of acute and chronic moderate to severe pain
gemcitabine and platinol followed by pemetrexed and gemcitabine in patients with advanced or metastatic bladder cancer

Conditions: Carcinoma, Transitional Cell

Summary: the purposes of this study are: to determine the maximum tolerated dose of gemcitabine and platinol followed by pemetrexed and gemcitabine in patients with advanced or metastatic transitional cell carcinoma of the urothelium; to determine the safety of gemcitabine and platinol followed by pemetrexed and gemcitabine and any side effects that might be associated with the combination of these drugs; to determine whether gemcitabine and platinol followed by pemetrexed and gemcitabine can help patients with advanced bladder cancer live longer; to determine whether gemcitabine and platinol followed by pemetrexed and gemcitabine can make your tumor smaller or disappear, and for how long.


Eligibility criteria:
inclusion criteria: * biopsy-proven metastatic bladder cancer * no prior chemotherapy for metastatic disease except before or after surgery, which was completed 6 months before enrollment * prior radiation allowed, if it is not the only site of measurable disease and if completed 3 weeks before enrollment * 18 years of age and older exclusion criteria: * pure adeno- or squamous urothelial cancer * brain metastases that causes symptoms * have not received treatment within the last 30 days with a drug that has not received regulatory approval for any indication * inability to take dexamethasone, folic acid or vitamin b12, according to the protocol * clinically relevant fluid collection in the lungs or abdomen that cannot be controlled
determination of in-vivo plasma aa appearance from plant protein fibre products

Conditions: Aging; Undernutrition; Appetite Loss; Age-Related Sarcopenia

Summary: this study aims to assess the digestibility and efficacy of the study groups previously developed innovative plant-based protein and fibre products.

older people are at high risk of undernutrition, which leads to serious adverse health outcomes, but effective preventive strategies are lacking. effective, new strategies should focus on the etiology of undernutrition and directly address potential causes and mechanisms underpinning undernutrition. reduced food intake and restricted dietary diversity are direct consequences of poor appetite. recent studies have shown, that older persons with a poor appetite demonstrate lower intake of protein and dietary fibre, and of several nutrient-rich food groups (e.g. meat, fish, wholegrains, vegetables), after adjustment for energy intake and other potential confounders, but a higher consumption of food groups low in micronutrients (e.g. fats, oils, sweets, and sodas), compared to those with good appetite. enhancing dietary protein and fibre intake in older europeans is a key objective because intake of both nutrients is sub- optimal, not only in those with poor appetite. adequate protein intake prevents excessive decline in muscle mass and function (sarcopenia), a widespread health-issue in older persons, intensified by undernutrition. adequate dietary fibre intake prevents constipation and impedes the development of many chronic diseases prevalent in older people. thus, targeting adequate protein and fibre intake may be particularly beneficial in this vulnerable population. a preparatory short-term study will be performed to assess in 10 healthy older adults the net peripheral amino acid (aa) appearance following ingestion of 3 selected plant-based proteins and fibre (ppf) products previously developed by the wider study collaborators, compared to the reference of 30 g whey protein. plasma concentrations of aa from arterialised blood will be measured by ion exchange chromatography in blood samples (1 drawn before and 6 during 3 hours postprandial). this step will allow the research group to compare in-vitro (previous work) and in-vivo digestibility of several ppf mixtures and identify the product with both optimal amino acid composition and sensory properties as well as optimal post-prandial plasma amino acid profile to be used in further studies.

Eligibility criteria:
inclusion criteria: * community-dwelling, age 65+ years, not a heavy smoker (≤10/day), bmi 18-30 kg/m2 exclusion criteria: * medical condition or medication known to impact appetite or energy intake, consumes more than 14 (female) or 21 (male) units of alcohol per week, inability to come to study centre, self-reported cognitive impairment or diagnosis of clinical depression, heavy smoker (\>10/day)

Keywords: amino acid gut hormones older adults successful ageing plant protein fibre
can ultrasound detect diabetic peripheral neuropathy?

Conditions: Distal Symmetric Polyneuropathy (DSPN)

Summary: the cross sectional area of posterior tibial nerve (ptn) is increased in diabetic patients with distal symmetric polyneuropathy (dspn) as compared to diabetic patients without dspn. this study aims to evaluate whether the cross sectional area of the posterior tibial nerve (ptn) as measured by ultrasound is increased in patients with distal symmetric polyneuropathy (dspn) as compared to diabetic patients without dspn.

regional anesthesia is associated with a low frequency of neurologic injury that can result in permanent deficit. it is believed that patients with neuropathies might be at higher risk of injury but detailed investigation of the diabetic patient is lacking yet anesthetic practices may be altered nevertheless. this study intends to investigate the appearance and sonographic qualities, as well as electrophysiologic measures, of the posterior tibial nerve (ptn) in diabetic patients undergoing nerve conduction studies in order to compare ptn characteristics between diabetic patients with peripheral neuropathy to those without. ultimately, we hope that ultrasound, a commonly used non-invasive tool, will be able to assist in the identification of patients at higher risk of injury from regional anesthesia

Eligibility criteria:
inclusion criteria: * type i diabetic patients (diagnosed more than 5 years), and type ii diabetic patients scheduled for routine ncs. exclusion criteria: * non-diabetic neuropathy caused by genetic, metabolic and inflammatory diseases as well as toxic agents and drug induced (eg. chemotherapy agents)

Keywords: distal symmetric polyneuropathy diabetic peripheral neuropathy posterior tibial nerve regional anesthesia nerve conduction study
postacute sarcopenia: supplementation with β-hydroxymethylbutyrate after resistance training

Conditions: Sarcopenia

Summary: a randomized, double-blind, placebo-controlled, parallel study to assess the effects of β-hydroxymethylbutyrate (β-hmb) combined with a resistance training program, after an acute process in older patients with sarcopenia in terms of muscle mass, muscle strength and physical performance. treatments compared will be β-hydroxymethylbutyrate (β-hmb) with a resistance training program or placebo with a resistance training program.

sarcopenia is a geriatric syndrome characterized by the loss of skeletal muscle mass and strength that occurs with advancing age; it is related to frailty, falls, worsening quality of life, and death in chronic and elderly patients. diagnosis of sarcopenia is based on clinical criteria: presence of low muscle mass and the presence of low muscle function and/or low physical performance. the latest developments indicate that dietary supplementation combined with resistance exercise could be an option to improve muscle mass and function. the objective of the study is to assess the effects of β-hydroxymethylbutyrate (β-hmb) combined with a resistance training program, after an acute process in older patients with sarcopenia in terms of muscle mass, muscle strength and physical performance. design: a randomized, double-blind, placebo-controlled, parallel study with two intervention groups. the investigators shall compare placebo against an intervention with β-hmb in patients performing a resistance training program after an acute process (post-acute period) during 12 weeks. there will be 16 patients in each arm of the study. additionally a one year follow up visit will be performed.

Eligibility criteria:
inclusion criteria: * male or female ≥60 years old * sarcopenia diagnosis and case-finding criteria following european working group on sarcopenia in older people (ewgsop) * being discharged from post-acute care geriatric unit for rehabilitation treatment * ambulatory prior to the recent acute process * cognitive situation that let them to understand and follow an active physical rehabilitation program (mini-mental status examination ≥21/30) * voluntary participation and being able and willing to provide an informed consent exclusion criteria: * potential participants will be excluded if they have active malignancy (exception basal or squamous cell skin carcinoma or carcinoma in situ of the uterine cervix) * major lower limb surgery over the past 6 months (knee or hip arthroplasty) * contraindication for resistance training * performed regular exercise in the last 6 months * use of any medications interfering with the nutritional intervention * serious clinical conditions that compromises and endanger the patient's life * contraindication, intolerance or allergy to β-hydroxymethylbutyrate

Keywords: beta hydroxy beta methylbutyrate older people muscle mass muscle strength post-acute
a study to assess the effects of multiple study drug regimens in subjects with newly diagnosed locally advanced head and neck squamous cell carcinoma

Conditions: Head and Neck Cancer

Summary: a study evaluating the safety, pharmacokinetics, and biomarker profiles of multiple study drugs as monotherapy in subjects with newly diagnosed, treatment-naïve locally advanced squamous cell carcinoma of the head and neck who are candidates for surgical resection.


Eligibility criteria:
inclusion criteria: * newly diagnosed stage 3 to 4b squamous cell carcinoma of the oral cavity, oropharynx, larynx, or hypopharynx who are candidates for surgical resection and are treatment-naïve. participants must have been determined to be candidates for surgical resection by a multidisciplinary team including a surgeon, a medical oncologist, and a radiation oncologist. * has an eastern cooperative oncology group (ecog) performance status of 0 to 1 and life expectancy of more than 3 months. * must consent to provide the tumor tissues for analyses as described in the protocol. * must have adequate bone marrow function (without any growth factors or transfusions within 2 weeks prior to the first dose), kidney and liver function, with all laboratory values criteria detailed in the protocol. exclusion criteria: * has received live vaccine within 28 days prior to the first dose of study drug. * has a history of inflammatory bowel disease, a history of or ongoing pneumonitis or interstitial lung disease, had major surgery ≤ 28 days prior to the first dose of study drug and the surgical wound is not fully healed. * participants with hypopharyngeal or laryngeal tumors will not be candidates for arm 4 of the study (it injection of abbv-927). * requires use of an immunosuppressive medication within 14 days prior to the first dose of the study drug; exceptions are described in the protocol. * has a confirmed positive test results for human immunodeficiency virus, or have active hepatitis a, b or c. * has a history of primary immunodeficiency, allogeneic bone marrow transplantation, solid organ transplantation, or previous clinical diagnosis of tuberculosis. * has a history of any other malignancy within the past 3 years except for successfully treated non-melanoma skin cancer or localized carcinoma in situ that is considered cured or adequately treated by the investigator.

Keywords: head and neck squamous cell carcinoma cancer abbv-927 abbv-368 abbv-181 tumor resection immunotherapeutic drug
the role of steroids following selective laser trabeculoplasty

Conditions: Glaucoma

Summary: to evaluate whether or not using topical steroids after selective laser trabeculoplasty affects intraocular pressure outcomes.

subjects undergoing bilateral slt will be randomly assigned to use prednisolone acetate 1% in one eye four times daily with no treatment in the fellow eye, for one week following slt. examinations will occur at baseline, and one week, one month and three months after slt. iop and anterior chamber inflammation will be noted at each visit.

Eligibility criteria:
inclusion criteria: * glaucoma or ocular hypertension * need for bilateral slt exclusion criteria: * eye disease precluding accurate iop measurement * contraindication to topical prednisolone acetate

Keywords: glaucoma trabeculoplasty steroids
transauricular vagal nerve stimulation; functional dyspepsia and gastroparesis

Conditions: Gastroparesis; Functional Dyspepsia; Healthy; Digestive System Disease; Gastroenterology

Summary: the goal of this study is to establish parameters of gastric myoelectrical activity and heart rate variability in healthy human subjects and compare and contrast them to those with gastroparesis and functional dyspepsia, at baseline and following tavns.

this is a prospective pilot study assessing the relationship of electrogastrography and heart rate variability, with transauricular stimulation of the vagal nerve in healthy subjects compared to gastroparesis and functional dyspepsia patients. the investigators plan to recruit a total of 60 patients: 20 healthy volunteers, 20 gastroparesis, and 20 functional dyspepsia patients. participants will undergo two testing sessions in which electrogastrography (egg) and heart rate variability (hrv) will be measured using electrodes following transauricular vagal nerve stimulation (tavns) at various frequencies.

Eligibility criteria:
inclusion criteria: 1. male or female. 2. age 18-85 years. 3. healthy volunteer or established diagnosis of idiopathic, diabetic, or postsurgical gastroparesis and functional dyspepsia. 4. patient is capable of giving informed consent. 5. patient is on stable doses of other medications for gastroparesis or functional dyspepsia for preceding 4 weeks prior to enrollment (including cholinergics, anti-cholinergics, dopamine and serotonin receptor agonists/antagonists, motility agents, neuromodulators, herbals). exclusion criteria: 1. any diagnosis of systemic autonomic dysfunction. 2. use of narcotic, anticholinergic, cholinergic, or promotility medications in preceding 2 weeks of study. 3. enteric feeding tubes. 4. parenteral nutrition. 5. severe disease flare requiring hospitalization or er visits within 3 months of study. 6. untreated depression or suicidal thoughts. 7. pregnant/breastfeeding women. 8. history of gastric pacemaker implantation. 9. implantable electronic devices (i.e. cardiac pacemakers) 10. extrinsic myopathy/neuropathy 11. vagal nerve injury. 12. high risk cardiac arrhythmias (high grade av block, atrial fibrillation, atrial flutter). 13. gerd. 14. history of dumping syndrome. 15. history of rapid gastric emptying. 16. severe allergy to skin adhesives. 17. concurrent enrollment in other clinical trials.

Keywords: vagal nerve stimulation egg gastroparesis functional dyspepsia auricular stanford digestive gastroenterology
optical coherence tomography angiography evaluation of ocular changes in patients with carotid artery stenosis

Conditions: Carotid Stenosis

Summary: this study aims to evaluate ocular changes in patients with carotid artery stenosis by optical coherence tomography angiography before and after carotid artery revascularization procedure.

a growing body of research indicates that abnormal ocular microvascular features may serve as a novel biomarker reflecting the severity of underlying cardiovascular, neurodegenerative, and microvascular disease. since blood flow to the retina is predominantly supplied by the internal carotid artery (ica), we hypothesized that ocular microvasculature and structure changes may reflect the disease status or therapeutic effects in patients with carotid artery stenosis. optical coherence tomography angiography (octa) is a novel, non-invasive imaging modality that can be a reliable tool for the qualitative and quantitative assessments of ocular vessels during various ocular pathological or physiological changes. recent studies have also demonstrated the ability of octa to quantify retinal microvascular changes in monitoring cardiovascular risk. this study aims to evaluate ocular changes in patients with carotid artery stenosis by optical coherence tomography angiography before and after carotid artery revascularization procedure.in this study, the patients with carotid artery stenosis and control group will receive a series of cerebral and ocular examinations including the most important cerebral ct perfusion (ctp) and octa. after that, the cerebral and ocular data between the two groups will be compared. also, the preoperative and postoperative data acquired will be compared.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of carotid artery stenosis * age-gender-race-matched controls exclusion criteria: * age \<18 years * intraocular pressure (iop) \>21 mmhg * va \>logmar 1.0 * spherical equivalent (se) between \>1.00 or \< -6.00 d * other serious eye diseases which may affect octa results including diabetic retinopathy, hypertensive retinopathy, retinal vascular occlusion, age-related macular degeneration, and uveitis * major intraocular surgery performed in the past 6 months or a history of laser photocoagulation or intravitreal injection * glaucoma or first-degree relatives with a history of glaucoma; and * any disease that might cause poor scan quality (image quality \<6).

Keywords: carotid stenosis octa
a neuroimaging and epigenetic investigation of antidepressants in depression

Conditions: Depression; Depression Secondary to Other Disease

Summary: the purpose of this study is: 1. to find out the structural or functional effects of selective serotonin reuptake inhibitors (ssri) in major depressive disorder (mdd); 2. find special abnormalities in depression secondary to other disease, e.g., autoimmune disease like systemic lupus erythematosus (sle). 3. find the relationship between the efficacy of antidepressant and the change of neuroimaging in mdd 4. to find possible predispose to mdd 5. to explore the dna methylation status in depression;

1. to explore the pathology of depression 2. to identify the difference between mdd and depression secondary to other disease ,especially autoimmune disease 3. to explore the effect of gene-environment interaction on the epigenetic regulation of the depression

Eligibility criteria:
inclusion criteria: * dsm-iv major depression or dysthymia * age 18-65 * physically healthy * drug-free exclusion criteria: * body metal (e.g., wire stitches, screws in bones, stainless steel hips) * history of psychosis or epilepsy * current (past six months) substance use disorder (illicit drugs and/or alcohol) * bipolar i * need for wash-out from effective treatment in order to participate * pregnant * high suicide risk * currently taking (within 2 weeks; 4 weeks for fluoxetine) antidepressants